Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
NEOMYCIN SULFATE BACITRACIN ZINC CYSTEINE THREONINE AMINOACETIC ACID
GlaxoSmithKline (Ireland) Limited
NEOMYCIN SULFATE BACITRACIN ZINC CYSTEINE THREONINE AMINOACETIC ACID
Cream
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-12-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1077/054/001 Case No: 2039664 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GLAXOSMITHKLINE (IRELAND) LTD STONEMASONS WAY, RATHFARNHAM, DUBLIN 16, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CICATRIN CREAM The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 21/11/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/11/2007_ _CRN 2039664_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cicatrin Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains: Neomycin Sulphate 3,300 units Bacitracin Zinc 250 units Glycine 10 mg L(+) Cysteine 2 mg DL-Threonine 1 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. A translucent deep yellow to brownish-yellow cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cicatrin Cream is broad-spectrum bactericidal preparations active against pathogens commonly found in infections of the skin. They are indicated in the prevention or treatment of superficial skin infection. These include: Prophylaxis in minor burns, cuts, scratches and abrasion সম্পূর্ণ নথি পড়ুন